Edge Pharma Phenylephrine HCl Syringes Recalled for Sterility Assurance
Edge Pharma, LLC is recalling Phenylephrine HCl 0.5 mg/5mL single-use syringes for intravenous injection nationwide due to lack of assurance of sterility. The affected product was distributed between September 2021 and January 2022.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug product. Loss of sterility assurance in an intravenous medication poses significant risk of serious injury or infection, meeting the threshold for Severe classification even though no hospitalizations or illnesses are explicitly reported in the source text.
Plain-English summary
Edge Pharma, LLC is recalling 3,747 syringes of Phenylephrine HCl 0.5 mg/5mL (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, NDC 05446-1545-05, manufactured at their facility in Colchester, Vermont.
The recall was issued because the manufacturer cannot assure the sterility of the product. Phenylephrine HCl is an injectable medication that must meet strict sterility standards for safe intravenous use.
The affected product was distributed nationwide with lot codes 09-2021-09@4 (expiration 12/22/2021) and 10-2021-14@1 (expiration 01/26/2022). Healthcare providers and patients who have this product should stop using it and contact their healthcare provider for guidance.
Consumers or healthcare professionals with questions or who believe they have been harmed should contact Edge Pharma, LLC or report the issue to the FDA.
The recalled product
- Product
- Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
- Manufacturer
- Edge Pharma, LLC
- Affected units
- 3,747
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 09-2021-09@4 12/22/2021 & 10-2021-14@1 01/26/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 56 products in this recall →Related recalls
Same manufacturer · Edge Pharma, LLC
See all →- ModerateProfound-PE Dental Gel Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-02
- SevereMVASI Sterile Ophthalmic Solution Lacks Assured Sterility
FDA (Drugs) · 2022-02-02
- ModerateLET Topical Gel drug recall for CGMP deviations
FDA (Drugs) · 2022-02-02
- SevereVancomycin HCl Injection Recalled for Sterility Assurance Issues
FDA (Drugs) · 2022-02-02
- ModerateCSF-HC Otic Powder Drug Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-02
Same hazard · sterility assurance
See all →- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
Similar recalls
- SevereAdvanced Pharma Recalls Phenylephrine HCl Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine HCl Injectable Syringes for Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SeverePharMEDium Recalls Phenylephrine Injection Due to Sterility Assurance Failure
FDA (Drugs) · 2018-02-21
- HighPhenylephrine HCl Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-27
- LowEdge Pharma Recalls Epinephrine/Lidocaine Ophthalmic Solution Due to Labeling Errors
FDA (Drugs) · 2021-03-24